Methods of generating compression garment measurement information for a patient body part or body area of interest and use thereof

ABSTRACT

The present invention relates to methods of generating a shape description from digital image acquisition for a patient body part or body area of interest and use of such shape description. Such shape description includes geometric information from which measurement information can optionally be derived. Included herein are methods for diagnosing and monitoring edema and other conditions in patients using shape descriptions acquired from a patient in need of such diagnosis and monitoring. The invention also includes use of the generated shape descriptions to make compression garments specifically configured for a patient&#39;s body part or body area. Compression garments generated from the shape descriptions are also included herein.

FIELD OF THE INVENTION

This application claims priority to U.S. Provisional Patent ApplicationNo. 62/372,891, filed Aug. 10, 2016. The disclosure of this applicationis incorporated herein in its entirety by this reference.

FIELD OF THE INVENTION

The present invention relates methods of generating a shape descriptionderived from digital imaging of a patient body part or body area ofinterest and use of such shape description. Such shape descriptionincludes geometric information from which measurement information canoptionally be derived. Included herein are methods for diagnosing andmonitoring edema and other conditions in patients using shapedescriptions acquired from a patient in need of such diagnosis andmonitoring. The invention also includes use of the generated shapedescriptions to make compression garments specifically configured for apatient's body part or body area. Compression garments generated fromthe generate shape descriptions are also included herein.

BACKGROUND OF THE INVENTION

“Edema” is the accumulation of excess fluid in a fluid compartment. Thisaccumulation can occur in the cells (i.e., cellular edema), in theintercellular spaces within tissue (i.e., interstitial edema), or inother spaces in the body. Edema can be caused by a variety of factors,including indications associated with osmotic pressure, such ashypotonic fluid overload, which allows the movement of water into theintracellular space, or hypoproteinemia, which decreases theconcentration of plasma proteins and permits the passage of fluid out ofthe blood vessels in to the tissue spaces. Other factors can includepoor lymphatic drainage (known as “lymphedema”), conditions associatedwith an increased capillary pressure (e.g., excessive retention of saltand/or water), heart failure, and conditions associated with increasedcapillary pressure, such as inflammation.

When a person is symptomatic of edema, early diagnosis and treatment isimperative. As swelling increases, more pressure is exerted onsurrounding cells, tissues and blood vessels. As these areas aresqueezed from the increase of fluid and from the natural body responseto increased inflammation (as a component of “first response” to aninjury), more tissues die, more fluids are released, and the amount ofedema presented increases. As edema increases, there is more potentialfor this “cascade effect” to continue, to result in even more damage.Thus, early diagnosis and regular patient monitoring can be critical toidentify swelling occurring prior to the generation of the “edemacascade.”

Compression garments can be used to prevent and or treat edema and anumber of conditions that cause swelling in patient body parts or bodyareas. In this regard, edema, which as indicated, presents as excessiveinterstitial fluid accumulation, may arise from a variety of illnessesand conditions, including venous valvular insufficiency, post-phleboticsyndrome, posttraumatic swelling, postoperative swelling, congestiveheart failure-related swelling, hypoalbuminemia-related swelling, druginduced swelling, and lymphedema

In the treatment of edema-like conditions, compression garments canaddress patient body part or body area swelling by increasing transportand reducing stagnation of interstitial fluids. Such interstitial fluidsoperate to increase nutrient delivery to tissue, remove waste fromtissues, reduce pain from swelling, and decrease the risk of infection.

In addition to therapeutic effectiveness, compression garments are anincreasingly popular clothing item worn by athletes and activeindividuals with the goal of enhancing recovery from exercise. While theactual mechanism of action for compression clothing remains largelyunknown today, it is generally hypothesized that when compressiongarments are used during recovery, muscle swelling is reduced.Improvements in recovery after exercise are seen by both men and women,who can be well-trained athletes or “weekend warriors.” Generally, itseems likely that compression garments display greater overall benefitsfollowing higher amounts of, or greater intensities of, exercise.Notwithstanding the lack of clear knowledge about how compressiongarments assist in athletic recovery, it is nonetheless important toprovide persons in need of treatment with compression garments that fitwell.

For therapeutic use, proper fitting of compression garments is importantif only because ill-fitting garments will not provide theintended/prescribed amount of compression therapy to the person beingtreated. Existing methods of fitting compression garments for a specificpatient are problematic, however. As would be understood, human bodyparts or body areas that may be fitted with compression garments are notregularly shaped, and some may be quite complex in surface shape ormorphology, such as in patients with advanced lymphedema or those whoare morbidly obese, for example.

A further concern in the design of a compression garment is patientcomfort. A compression garment may provide proper compressioncharacteristics, but if the wearer experiences discomfort due topinching, chaffing, buckling, or other reasons, she is unlikely to becompliant in wearing the compression garment and, thus, may not achievetherapeutic benefits. For example, the noncompliance rate for graduatedcompression stockings has been reported to be 30%-65%. Commonly citedreasons include, among other things, pain, discomfort, difficultydonning the stockings, perceived ineffectiveness, excessive heat, andskin irritation. Of course, if a patient fails to wear a compressiongarment that is prescribed for a potentially chronic or already chroniccondition, that condition can become worse and, perhaps, irreversibledamage could result. Thus, improved patient compression garmentcompliance is a need today.

The compression garment must be able to apply the intended/prescribedcompression levels and compression gradients for each area of anaffected body part. The proper compression gradients must be applied inthe proper direction (or “vectors”). In other words, in use, acompression garment must have the properties of good fit and appropriatetherapeutic compression gradient values to effectively provide theintended/prescribed level of compression therapy to a person in needthereof, as well as to prevent harm from occurring to the patient causedby a poorly fitting garment.

Given the vast variation in human body shapes, custom garments can beindicated to provide optimum therapeutic benefits. Traditionally,compression garment fitting has been conducted primarily by use of atape measure. While tape measurement techniques are widely available toa broad scope of medical providers, the technique generally suffers frompoor accuracy. In short, tape measurement is not a very effectivegarment measurement tool because the technique has been shown to exhibitas much as an about 8 to about 12% inaccuracy due to inter andintra-operator variability. Such variability gives rise to a need formethods of measurement that demonstrate improvements in both accuracyand precision.

In therapeutic settings, patients often receive a recommendation for acustom fit garment, even though a custom fit garment is often far moreexpensive than an off-the-shelf compression garment. The time needed togenerate such custom fit garments is long: the patient must be measuredby a trained technician, and such measurements must be forwarded to agarment manufacturer, before the garments can be placed in a queue formanufacturing.

As noted, the current methodology used to fit compression garments isoften inaccurate. Thus, using current fitting methodology, evenexpensive custom fit garments may not fit properly even when they arenew. This means that, once the garments are sent back from themanufacturer, the fit quality must be checked by the technician and/ormedical provider to make sure that the fit is therapeutically correct,thus necessitating further delays and increased cost in ensuring properpatient treatment. Often these custom-made compression garments must beremade; the fit error rate has been estimated to be from about 15 toabout 40%. For chronic conditions, such as lymphedema or diabetic limbindications, such delay can cause irreversible harm to the patient. As ageneral rule, compression garments are usually only guaranteed to beeffective for a life of six months, this cycle must be repeatedregularly, which can reduce patient compliance, as well as greatlyadding to the cost of treatment given the high amount of in-person timea patient requires to ensure proper fit of the compression garment.

For off-the-shelf compression garments, a person is often left withinsufficient information when trying to select the appropriatecompression garment. Such off-the-shelf garments are generally selectedusing a manufacturer's sizing chart and starting pressure levels thatare provided by manufacturers. Pressure ranges for such compressiongarments can apply to a given range of circumferences. Thiscircumference range is often large, which may make it more difficult tounderstand the compression provided by the garment, especially beyond aninitial distal measurement. An individual consumer may fit into severalsizes or have parts of his or her arm that fit into different sizes. Asa result, the user may end up with ill-fitting compression garmentsthat, at best, provide limited benefits, and, at worst, can end upcausing harm to the user. Nonetheless, such off-the-shelf garmentsremain the status quo for those seeking lower cost compression garments.

Further, even if a consumer or clinician has a compression chart withdetailed compression gradient information for a particular compressiongarment design, the fitting of compression garments may still beproblematic. It can be difficult to decide upon a size and compressionclass that will meet all specifications of a particular individual. Forexample, there may be multiple points on a patient where the garmentmust meet compression specifications. Specifications can requiregraduated compression gradient values, meaning that compression mustvary by a given amount along the length of a limb, for example.Individuals may also have specific characteristics, such as compressionsensitivity and varying degrees of swelling in various limb locations,muscle shape, etc., which can create even greater complexity in theselection process. The locations for such body part structuralvariations will necessarily be specific to the individual.

The true external shape of the body part or body area, called“morphology” herein, being fitted for compression garments will bedifficult to reproduce using the standard compression garment fittingmethod of using a tape measure. Tape measures will only identifydifferences in body part morphology to the extent that a large number ofexternal measurements are made. Since large variations in body partshape can be seen in short distances along the surface of a body part,the conventional tape measurement method cannot generate a shape for thebody part or body area being fitted. As such, many custom fittedcompression garments often do not provide the desired amount ofcompression along the whole of the body part or body area being treatedwith the compression garment. More recently, three-dimensional imagingof a body part or body area has been proposed, however, such methodshave not been found to provide clinically accurate reproductions, asdiscussed in more detail hereinafter.

Still further, certain persons may be interested in obtaining garmentsthat are specifically sized to fit their bodies. Such “custom-fit”garments have traditionally been available only from tailors orseamstresses, and have accordingly been quite expensive and thereforegenerally out of reach of the average clothing consumer. Yet further,the lack of regulated sizes in the clothing industry makes it difficultfor a person to know whether a particular garment will fit her. This notonly makes trying on clothes in a retail establishment time consumingfor shoppers, but also makes purchase of clothing online particularlychallenging.

There remains a need for improved methods of generating accurate shapeinformation for a patient's body part or body area, where such shapeinformation can be used to diagnose and monitor edema and otherconditions in a patient. Still further, there remains a need forimprovements in the fitting of compression garments for use by aspecific patient in need of treatment with compression therapy. Yetfurther, there remains a need for compression garments that closelymatch the shape of the body part or body area being fitted with thecompression garment. The present invention provides this and otherbenefits.

SUMMARY OF THE INVENTION

Aspects of the present disclosure are related to methods of generating ashape description from digital images for a body part or body area ofinterest and use of such shape description information. The generatedshape description information can be used to make compression garmentsspecifically configured for the body part or body area. Compressiongarments generated from the shape description information are alsoincluded herein.

In one aspect, among others, a method for making a compression garmentcomprises selecting a body part or body area of interest in a patient inneed of compression thereby, the body part or body area having a surfacemorphology of that patient; acquiring digital images of the selectedbody part or body area; processing the digital images by a computingdevice, wherein: the processing of the digital images comprisesgenerating shape description information for the selected body part orbody area; the generated shape description information comprisesgeometric information for the selected body part or body area, thegeometric information being associated with the surface morphology ofthe selected body part or body area of the patient; and measurementinformation for the selected body part or body area can optionally bederived from the shape description information; providing at least onecompression gradient value identified as therapeutically appropriate toprovide compression therapy to the patient when the at least onecompression gradient value is incorporated into a compression garmentfabricated from the shape description information or the optionalmeasurement information; and fabricating the compression garment fromthe shape description information or the optional measurementinformation, wherein the fabricated compression garment incorporates theprovided compression gradient value. In one or more aspects, theselected body part or body area can be at least part of one arm or atleast part of one leg. The digital images can be acquired by an operatormoving an imaging device around the selected body part or body area ofinterest. The imaging device can be free to move around the selectedbody part or body area with six degrees of freedom, unconstrained by amounting or support assembly. In various aspects, the digital images maynot be acquired by rotation of an imaging device on a path about a fixedaxis around the patient or by rotation of the patient on a platform.

In one or more aspects, the operator can observe a digital imageacquisition report in substantially real time during the digital imageacquisition step, wherein the image acquisition report includesinformation about a three-dimensional reconstruction of the selectedbody part or body area, and wherein the operator can adjust the digitalimage acquisition in response to the received information. The digitalimage acquisition report can be presented to the operator on a screenthat is in operational engagement with the image capture device. Theselected body part or body area can comprise at least one knob or lobe,the surface morphology of the patient thereby comprising a complexsurface morphology for the selected body part or body area. Thecompression garment can comprise geometric features associated with theselected body part or body area that reduce pinching or chaffing of thepatient. In various aspects, the compression garment can be in the formof an arm sleeve, wherein the provided compression gradient value isfrom about 20 to about 50 mm Hg, wherein the compression gradient isincorporated in an area distal from a top end of the sleeve, and whereinthe top end is proximal to either an elbow area or a shoulder area onthe patient. The compression garment can comprise geometric featuresassociated with the selected body part or body area that reduce pinchingor chaffing of the patient. The compression garment can comprisegeometric features associated with a bony area of the selected body partor body area identified by the shape description information. In someaspects, the compression garment can be in the form of a leg covering,wherein the compression gradient value can be from about 20 to about 50mm Hg, wherein the compression gradient value can be incorporated in anarea distal to a top end of the covering, and wherein the top end can beproximal to either a knee area or a thigh area on the patient. Thecompression garment can comprise geometric features associated with abony area of the selected body part or body area identified by the shapedescription information. In one or more aspects, at least part of theselected body part or body area substantially does not comprise acircular cross-sectional area.

The identified embodiments and aspects are exemplary only and aretherefore non-limiting. The details of one or more non-limitingembodiments of the invention are set forth in the accompanying drawingsand the descriptions below. Other systems, methods, features, andadvantages of the present disclosure will be or become apparent to onewith skill in the art upon examination of the following drawings anddetailed description. It is intended that all such additional systems,methods, features, and advantages be included within this description,be within the scope of the present disclosure, and be protected by theaccompanying claims. In addition, all optional and preferred featuresand modifications of the described embodiments are usable in all aspectsof the disclosure taught herein. Furthermore, the individual features ofthe dependent claims, as well as all optional and preferred features andmodifications of the described embodiments are combinable andinterchangeable with one another.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a non-circular cross-section indicative of an arm.

FIG. 2 illustrates images of a patient with Stage 3 lymphedema on alower leg.

FIG. 3 illustrates a collection of compression garment configurationsthat can be generated with the methodology of the present invention.

FIG. 4 provides an overview of a process of the present invention.

FIG. 5 is a schematic diagram illustrating an example of a computingsystem for implementing body shape description and measurement, inaccordance with various embodiments of the present disclosure.

FIG. 6 illustrates a point cloud generated from a plurality of digitalimages of a patient's leg, where a shape description and measurementinformation can be derived therefrom.

FIG. 7 shows part of an image acquisition technique for a handheldtechnique.

DETAILED DESCRIPTION OF THE INVENTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof, and within which areshown by way of illustration certain embodiments by which the subjectmatter of this disclosure may be practiced. It is to be understood thatother embodiments may be utilized and structural changes may be madewithout departing from the scope of the disclosure. In other words,illustrative embodiments and aspects are described below. But it will ofcourse be appreciated that in the development of any such actualembodiment, numerous implementation-specific decisions must be made toachieve the developers' specific goals, such as compliance withsystem-related and business-related constraints, which may vary from oneimplementation to another. Moreover, it will be appreciated that suchdevelopment effort might be complex and time-consuming, but wouldnevertheless be a routine undertaking for those of ordinary skill in theart having the benefit of this disclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as is commonly understood by one of ordinary skillin the art to which this disclosure belongs. In the event that there isa plurality of definitions for a term herein, those in this sectionprevail unless stated otherwise.

Where ever the phrases “for example,” “such as,” “including” and thelike are used herein, the phrase “and without limitation” is understoodto follow unless explicitly stated otherwise.

The terms “comprising” and “including” and “involving” (and similarly“comprises” and “includes” and “involves”) are used interchangeably andmean the same thing. Specifically, each of the terms is definedconsistent with the common United States patent law definition of“comprising” and is therefore interpreted to be an open term meaning “atleast the following” and is also interpreted not to exclude additionalfeatures, limitations, aspects, etc.

The term “consisting essentially of” is meant to exclude any featuresthat would change the basic and novel characteristics of the presentinvention, as claimed.

The term “about” is meant to account for variations due to experimentalerror. All measurements or numbers are implicitly understood to bemodified by the word about, even if the measurement or number is notexplicitly modified by the word about.

The term “substantially” (or alternatively “effectively”) is meant topermit deviations from the descriptive term that don't negatively impactthe intended purpose. Descriptive terms are implicitly understood to bemodified by the word substantially, even if the term is not explicitlymodified by the word substantially.

“Edema” is the accumulation of excess fluid in a fluid compartment. Thisaccumulation can occur in the cells (i.e., cellular edema), in theintercellular spaces within tissue (i.e., interstitial edema), or inother spaces in the body. Edema can be caused by a variety of factors,including indications associated with osmotic pressure, such asashypotonic fluid overload, which allows the movement of water into theintracellular space, or hypoproteinemia, which decreases theconcentration of plasma proteins and permits the passage of fluid out ofthe blood vessels in to the tissue spaces. Other factors can includepoor lymphatic drainage (known as “lymphedema”), conditions associatedwith an increased capillary pressure (e.g., excessive retention of saltand/or water), heart failure, and conditions associated with increasedcapillary pressure, such as inflammation (e.g., burns or other trauma).

As used herein, the phrase “detecting edema” or “diagnosing edema” meansdetecting or diagnosing the existence of edema, as well as the onset ofedema, early stage edema and the progression of edema over time. Thus,methods for detecting edema can also be used to monitor the progressionof edema over time and treat/manage edema in an individual.

The term “lymphedema” may include either primary or secondarylymphedema, the latter of which might also be term “acquired”lymphedema. Some forms of lymphedema can occur in morbidly obesepatients, such as the condition known clinically as “Massively LocalizedLymphedema.” Lymphedema is a category of edema, although it is alsocharacterized as a separately treatable indication, such as when it is acomplication of breast cancer treatments in which lymph activity inpatients is affected. As would be recognized, primary lymphedema iscaused by abnormal development of the lymph system. Symptoms can bepresent at birth, or may appear later in life. Secondary lymphedema iscaused by damage to the lymphatic system. The lymphatic system may bedisrupted, damaged or blocked by infection, injury, cancer, removal oflymph nodes, radiation to the affected area or scar tissue fromradiation therapy or surgery. In some aspects, the present inventionprovides methods of detection of lymphedema that occurs as a result ofremoval or damage to lymph nodes that occurs after treatment of apatient for breast cancer.

“Compression garment” as used herein means garments that are constructedfrom elastic material and that are intended to apply pressure whenstretched over the skin while being worn. Compression garments are wornover an area of the body where a therapeutic response (e.g., fortreatment of lymphedema or swelling post-surgery etc.) or, when used insports-related applications, enhanced recovery of a person afterathletic assertion is intended. Typically, compression garments compriseone or more compression gradients that, when worn by a patient in needof treatment, are configured to apply an intended or prescribed level ofcompression therapy to the patient. When a person is wearing compressiongarments that are properly sized and fitted for that person's limb,trunk or extremity, etc., such garments apply a pressure to the skinthat is generally dependent on both the material construction and thesize and the shape of the garment, and how well the garment conforms tothe unique aspects of the wearer's shape. An intended or prescribedlevel of compression therapy for a patient in need of treatment is theselection of one or more compression gradients to be applied to thepatient during the wearing of a compression garment.

“Anthropometry” means the measurement of the size and proportions of thehuman body. “Anthropometric measurements” are measurements that compriseinformation regarding the contour, volume, overall size and otherrelevant information, where such information has relevance to thefitting of garments that are specifically sized for a person in need offitting for such garments.

In broad constructs, the present invention provides advancements ingeneration of mathematically accurate information about the shape of abody part or body area in a person or, if in a medical context, apatient. A patient can be a human or an animal. In some aspects, theinventive methodologies herein provide improvements in the ability todetect edema and other conditions associated with swelling of a bodypart or body part area, as well as being useful in generatingcompression garments from such mathematically accurate information,where such compression garments are derived from imaging of such bodypart or body part areas.

The inventive enhancements can be attributed to, at least in part, theincorporation of shape description techniques to derive accuratenumerical information about the shape of the body part or body area ofinterest in a three-dimensional coordinate system, wherein shapecomprises geometric—that is, numerically based—information that isinvariant to translation, rotation, and scaling.

Such numerically based shape information is to be distinguished fromprior art imaging techniques for body part and body areas where a shaperepresentation is derived therefrom. Shape representation methods resultin a non-numeric representation of the original shape (e.g., a graphicalrepresentation), where certain aspects of the shape are preserved, sothat the shape can be processed from that representation. Accurategeometry—that is, mathematical information—is not directly derivablefrom a shape representation. In other words, the measurements of thesubject object, such as a body part or body area in the presentinvention, can only be approximated or determined indirectly by using areference scale using shape representation methodology. Suchmeasurements require generation of an accurate and scale invariantreference scale in order to have utility.

In contrast, a shape description results from a processing stepsubsequent to shape representation, whereby the unique aspects of theshape of the object in the image can be derived accurately ingeometric/numerical form. In this regard, accurate numerical informationabout one or more unique features of the shape of interest—here a bodypart or body part area—are derivable from the plurality of acquireddigital images.

Specifically, in the context of the enhancements possible with thepresent methodology, a person or patient's unique body part or body areasurface morphology characteristics are derivable herein. Such surfacemorphologies are provided by the generation of a shape description forthe selected body part or body part area that are derived from shapeanalysis techniques known to those of skill in the art.

In one aspect, the Laplace-Beltrami equation:

${{\Delta \; u} \equiv {{\frac{\partial}{\partial\xi}\left( \frac{{F\frac{\partial u}{\partial\eta}} - {G\frac{\partial u}{\partial\xi}}}{\sqrt{{EG} - F^{2}}} \right)} + {\frac{\partial}{\partial\eta}\left( \frac{{F\frac{\partial u}{\partial\xi}} - {E\frac{\partial u}{\partial\eta}}}{\sqrt{{EG} - F^{2}}} \right)}}} = 0.$

can be used to resolve the shapes of the body part or body area ofinterest. Still further, Fourier Descriptors or Turning Functions can beused as discussed in R. C. Gonzalez and R. E. Woods, Digital ImageProcessing, Englewood Cliffs, N.J.: Prentice Hall, 2007, and Volotão,Carlos FS, et al., “Shape characterization with turning functions,”Proceedings of the 17th international conference on systems, signals andimage processing, Editora da Universidade Federal Fluminense. Vol. 1,2010, respectively, the disclosures of which are incorporated herein byreference in their entireties.

The inventive methodology can generate shape description informationabout one or a plurality of patient areas along a body part or bodyareas, such as all or part of a leg, an arm, neck, torso etc., wheresuch shape description information can be utilized in assessing theamount of swelling on a specific person on a longitudinal basis, such asfrom day to day, week to week, month to month, and year to year, forexample.

In their work with patients symptomatic of edema, the inventors hereinhave determined that existing three-dimensional digital imaging of bodypart and body areas for analysis, while generating depth maps and theassociated point clouds for analysis, nonetheless do not providesuitably accurate clinical results. All of the reviewed prior artimaging methodology intentionally reduce the complexity of the generatedpoint clouds so as to generate measurements of the body part or bodyarea of interest. For example, Isobar Compression, a company thatgenerates compression garments from digital imaging (seehttp://wwvv.isobar-compression.com/) specifically refers todown-sampling the point cloud to generate transverse cross-sectionalmeasurements with limited metric extraction (circumference, radius ofcurvature, etc.). Said differently, all prior art methods known to theinventors herein discretizes the point cloud to provide simple one andtwo-dimensional measurements.

The reason for all prior art simplifying the measurement process isbelieved by the inventors herein to: (1) address the mathematicalcomplexity involved in generating more advanced geometric information(i.e., it is not a trivial step to progress from simple one or twodimensional cross-sectional measurements to detailed shape descriptionin 3 dimensions); and (2) a lack of knowledge of the need and value ofgeometric analysis in diagnosing conditions and/or designing garmentsfor patients in need of treatment with compression therapy, as providedby the inventors herein.

As to the latter, the inventors herein have discovered that accuratediagnosis and monitoring of edema, and other conditions, as well as thesizing and fit of compression garments specifically configured for theperson, can be greatly improved by generation of three-dimensionalgeometric information from the digital images by way of the generatedpoint clouds.

Moreover, the inventive image acquisition processes suitably generatepoint cloud information that is optimizable to generate geometricinformation that is relevant to patients with edema and similarconditions, which is a specific clinical insight of the inventorsherein.

The quality of prior art body part or body area measurement informationwas also believed constrained by the use of a discrete set of elementsassociated with the body part or body area of interest, namely, length,circumference at defined intervals, which were used to generatemeasurement information that could not resolve the unique surfacemorphological features associable with a specific patient's body part orbody area. Such prior art measurement techniques have been found by theinventors herein to not allow the generation of fully accurate,geometrically-based, 3D representations of a patient's body part or bodypart area, at least in regard to unique surface morphologies for thatpatient. This, in turn, was found to limit the diagnostic andtherapeutic effectiveness of the measurement information so obtained.

Prior art methodology generally uses a series of “stacked”cross-sections to represent a limb, for example, as cross-sectional“slices” provided in a defined thickness interval (e.g., mm, cm, etc.)Using these prior art models, the geometry of a limb, for example, istherefore only understood in a series of transverse sections, that are“generically” reconstructed to provide information substantially withoutcharacterization of unique morphological features of that patient. Theinventors herein have determined after extensive analysis that suchprior art methodologies do not comprise enough information about thesubject body part or body part area for some relevant use cases.

In some aspects, the inventive methodology includes axial measurementsto generate the shape description, and associated information. Suchaxial measurements can be in the form of surface lines substantiallyspanning the length of the patient body part or body area of interest.Such surface lines can be spaced at a degree Θ around the body part orbody area of interest. The inventive methodology can therefore beconducted in multiple planes and in multiple dimensions to allowacquisition of a shape description which, in turn, results in higherquality measurement information for analysis and use.

As an illustrative example, consider a patient who exhibits swelling onthe outer side of her forearm. Using a prior art methodology, avolume-based measurement (that is, methodology that considers armgeometry to be an approximation of a cylinder) would indicate that thereis swelling in the forearm, but information about the precise locationof such swelling would be absent. Analysis of circumference measurementscould indicate that swelling was occurring in the forearm, but not whichside of the forearm the swelling was presenting. Radius of curvatureinformation could indicate that the forearm has more of less curvaturealong the length thereof, but information about the precise degree ofcurvature would be lacking. Circumference would indicate that forearmswelling has gone down and upper arm swelling has gone up but noinformation about which side of the arm the swelling was presenting.

In contrast, shape description and the mathematically accurateinformation derivable therefrom, such as provided with the inventivemethodology, can provide a markedly higher degree of detail as to theexact location of swelling on the forearm on a specific patient, as wellas the size thereof. The present invention allows the unique surfacemorphology of a specific patient to be resolved from digital imaging ofa body part or body area on that person. Shape description andassociated mathematically accurate information derivable from digitalimaging conducted over time can also provide the exact degree to whichthe shape characteristics of this patient's forearm and on her upper armhave changed, which would further inform ongoing treatment of thispatient and to allow compression garments fitted to the specificmorphological characteristics of this patient to be appropriatelyfabricated. In this regard, the inventive methodology has been found togenerate enhanced geometric information about the forearm and anymorphologies thereon, such as the “bump” indicated by swelling. In otherwords, the use of shape description allows one to determine not onlythat the bump is present and its size on this patient, but also wherethe bump is positioned in three-dimensional space, which is determinedbased upon shape description of the surface boundary.

In further aspects, the enhanced measurement information derived from animaged body part or body part area has been found to enable improveddiagnosis and monitoring capability, as well as allowing generation oftherapeutic direction for that patient. Such enhanced information hasbeen found to be highly relevant to understanding changes in theswelling of a specific patient's limb or a body part over a time period,and to generate a well-fitting compression garment that suitably appliesa prescribed level of compression therapy.

Turning back to the example of the patient with a bump on her forearm, aprescribed therapy, such as massage therapy, could result in the bumpmoving to another location on her arm, perhaps as far away as the upperarm. Without use of the inventive technique that applies shapedescription to generate precise information about the surface morphologyof the specific patient at each imaging event from which shapedescription information is obtained, knowledge about the effectiveness(or lack thereof) of the prescribed treatment would be lacking if theimaging technique only reported a volume measurement, as is the casewith prior art measurement techniques. This would be an incorrectclinical determination. In contrast, the inventive information derivedfrom shape description techniques would instead return detail about notonly about the movement of the swelling within the arm, but also itssize and location on the arm, thus allowing, among other things, aclinical assessment that takes into consideration the effect of theprescribed treatment, massage therapy in this example. This can allow aclinician or other medical provider to generate a treatment plan basedon actual knowledge of the effects of an applied treatment, includingcompression therapy as discussed elsewhere herein.

It has been found that a first highly accurate three-dimensionaldepiction of a patient's specific body part or body area shape ormorphology, such as is possible with the shape descriptions herein, canserve as a baseline for monitoring of subsequent changes in that samebody part or body area morphology, thereby providing predictive insightas to ongoing symptoms of a patient with actual or potential edema.

It has also been found that information about a specific patient'ssurface morphology as is derivable with shape descriptions for a bodypart or body part area can be especially useful when generatinginformation in patients having complex surface morphologies, such asthose with nodes or lobes on their body surfaces, for example, as occurswith people with high levels of edema and/or who might be morbidlyobese.

Notably, people who are symptomatic of edema may also be obese. Patientswith complex surface morphologies are often the hardest patients todiagnose for edema and similar conditions due to their highly irregularbody part or body area shapes. When using prior art imagingmethodologies in the detection of the potential progression of edema,the complex surface morphologies of such patients have been found togreatly reduce the effectiveness of detection. Acquisition of geometricinformation associated with the specific patient's body part or bodyarea of interest is possible with generation of a surface descriptionthat can be used to generate measurement information for the patient'sbody part or body area of interest has been found to greatly improve thequality of clinical information available for that patient.

With the present invention, diagnosis and monitoring ability is improvedover prior art imaging methodology for at least these patients.Moreover, the ability to generate well-fitting compression garments thatare constructed to deliver a prescribed one or more compressiongradients to a patient having complex surface morphologies is greatlyenhanced, at least because the garment is highly fitted—orcustomized—for the specific body part or body area of that patient, evenin view of her non-uniform skin surface configuration.

Beyond the specific subset of patients having complex surfacemorphologies, the inventors herein have determined that measurement ofbody parts or body areas using the standard tape measure technique orprior art imaging methodology cannot suitably generate a compressiongarment fit that substantially conforms to the shape of the patient'sbody part that is in need of compression treatment as is indicated by acompression gradient prescription generated by a provider. In thisregard, it has been determined that circumference measurements taken bythe tape measurement technique do not provide accurate information aboutthe shape of the parts, and subparts, of the body regions being measuredfor fitting with compression garments. Moreover, prior art imagingtechniques extract the circumferences of the body parts or body areas ofinterest. When a body part or body area are assumed to be a circle,which is the case with measurements of body parts or body areas takenaccording to these prior art methods, a circle, an ellipse, and a squaremay each demonstrate the same “circumference,” but, as would berecognized, would present markedly different shapes.

Prior art compression garments measured according to the prior artmethodology are constructed on the premise that the body part beingfitted essentially has a circular cross section, even while the person'sarm (or other body part) may, in fact, deviate substantially from acircle along the length thereof. The inventors have determined that theflawed assumption of a circular cross-section can, in turn, distort thepressure applied to the body part to which compression therapy is beingapplied. Such distorted pressure will result in a deviation in all orpart of the intended pressure gradients being applied to the body partby the compression garment. Accordingly, the effectiveness of thecompression garment generated from only circumferential and lengthmeasurements when the patient's body part being treated with compressiondeviates from the assumed cylindrical cross section. FIG. 1 shows anexample of a non-circular cross-section of an arm.

In notable aspects, the methodology herein allows the generation ofhighly accurate geometric information for a patient's body part or bodyarea of interest by generating one or more shape descriptions for thatbody part or body area. Generation of shape descriptions for the bodypart or body area of interest in a specific patient providesignificantly enhanced measurement information as compared to thetraditional circumference and length measurements used to generatecompression garments. Accordingly, the inventive methodology can be usedto generate accurate, geometrically-based, 3D representations for aspecific patient body part or body area of interest.

With specific reference to prior art three-dimensional digital imagingof body part and body areas for analysis of lymphedema, all such digitalimaging methods reviewed by the inventors herein generate point cloudsfor analysis. However, all of these prior art methods intentionallyreduce the complexity of the point cloud in order to extractmeasurements of the body part or body area of interest. For example,Isobar Compression, a company that generates compression garments fromdigital imaging (see http://www.isobar-compression.com/) specificallyrefers to down-sampling the point cloud to generate transversecross-sectional measurements with limited metric extraction(circumference, radius of curvature, etc.). Said differently, allreviewed prior art discretizes the point cloud to simple one andtwo-dimensional measurements.

Further with regard to the clinical realization, the inventors hereinhave discovered that accurate diagnosis and monitoring of edema, andother conditions, as well as the sizing and fit of compression garmentsspecifically configured for the person, can be greatly improved bygeneration of three-dimensional geometric information from the digitalimages by way of the generated point clouds. Moreover, the inventiveimage acquisition processes suitably generate point cloud informationthat is optimizable to generate geometric information that is relevantto patients with edema and similar conditions, which is a specificclinical insight of the inventors herein.

Yet further, the use of shape description information that is highlyaccurate as to a specific person has been determined by the inventorsherein to allow the addition of features such as mobility regions forelbows and knees that, when included in a compression garment derivedfrom such measurement information, has been found to improve fit andpatient compliance. In this regard, areas of the patient having specificmorphological characteristics (e.g., curves, bends, sharpness, etc.) canbe substantially identified and incorporated into shape descriptions andassociated information according to the methodology herein, and acompression garment generated that is substantially matched to thepatient's precise surface morphology can be generated. Incorporation ofsuch patient specific surface morphology into a compression garment,such as geometric features associated with bony areas on the patient'selbow, can reduce the propensity of the compression garment to causefriction sores on the patient during wearing thereof, for example. Inaddition, the compression garment can include non-compressive materialsor openings at bony areas or joints to reduce or eliminate pain,irritation or restriction of movement. These can be identified by themorphological characteristics of the shape descriptions.

Moreover, the inventors herein have found that with better fittingcompression garments and compression garments having shapes that moreclosely match those of the body part or body area of interest, resultantpressures applied from the garment will be much closer to the pressureprescribed by the clinicians, which is expected to result inimprovements in therapeutic outcomes. For example, a clinical conditionof “massively localized lymphedema,” is occurring in greater frequencyin persons who are morbidly obese. Such patients typical presentclinically with a large fold or lobe extending from an upper area of thethigh to extend typically down to the knee area. Compression therapy isoften indicated for such patients, however, the complex surfacemorphology results in a difficult fitting procedure that can result in acompression garment that likely only approximates the shape of thepatient area being treated. Using the imaging methodology of the presentinvention, digital images can be processed to derive a shape descriptionof the patient's body part or body area—here the patient's upper legregion—which can be rendered into measurement information thatsubstantially matches the unique surface morphology of the patient tothereby allow highly customized compression garments to be obtained.Such processing incorporates a step of “stitching” or “fusing” of thedigital images together, so as to derive the shape description. FIG. 2shows a further example of a complex patient surface morphologyresulting from a lower leg stage 3 lymphedema presentation.

In further aspects, the methodology herein allows compression garmentsto be generated, wherein the compression garments are substantiallymatched to the surface morphology of an individual person, in otherwords, the garments are customized for the person in need of compressiontherapy. As would be recognized, compression therapy is indicated forconditions involving venous and lymphatic insufficiency in the lowerlimbs, including varicosities, lymphedema, venous eczema and ulceration,burn treatments, deep vein thrombosis and post-thrombotic syndrome,among others. A person, for example, a patient with actual or potentialsymptoms of edema or the like, can be imaged along at least part of onebody part or body part area of interest to generate digital images ofthe body part or body area of interest that can be rendered into shapedescriptions and associated information derivable therefrom that issubstantially matched to the specific patient's body part or body partarea.

Compression garment fit parameters are defined for a patient by aprovider using prescribed compression gradient information. Gradientcompression garments apply more pressure distally while graduallydecreasing pressure as the garment travels up the extremity. Gradientcompression helps encourage and facilitate fluid movement for patientsaffected by lymphatic and venous disorders. With appropriate compressiongradient application, vessels in the circulatory and lymphatic systemscan absorb more fluid from tissues. The result is increased absorptionof tissue fluid and decreased swelling.

Compression garments can be indicated for the lower extremities in theform of leg stockings, such as disclosed in US Patent ApplicationPublication No. 20150051524, the disclosure of which is incorporatedherein in its entirety by this reference. The '524 Publication disclosescompression stockings in which compression gradients for therapeuticeffect are incorporated therein. Such compression garments can begenerated from information obtained according to the inventivemethodology herein. Compression garments having prescribed compressiongradients therein can also be indicated for the upper body and arms inthe form of compression sleeves for the arm, worn with or without a handcomponent (e.g., fingerless glove or a gauntlet that does not haveindividual finger openings), or a support bra for the chest area or avest for the entire trunk area.

A variety of compression garment configurations are derivable from themethodologies herein. Such configurations include, but are not limitedto those illustrated in FIG. 3. Other variations can also be generated,as indicated by the patient's condition. In order to suitably generatesuch compression garments having a prescribed compression gradientprescription incorporated therein for a patient in need of treatment,the methodology herein can be used to obtain measurement informationderived from shape descriptions generated from imaging of the body partor body area of interest as discussed further herein. Fabricationinstructions can be generated from such measurement information. Stillfurther, generated shape descriptions can be used to generate suitablefabrication instructions.

TABLE 1 TYPES OF COMPRESSION GARMENTS A-knee high B-thigh high C-fullleg D-full leg E-full leg F-chest G-panty stocking stocking stockingstocking stockings high girdle one leg One leg chap style with brief twolegs stockings (above one leg one leg (open for knee (open crotchpregnancy shown, crotch shown, two legs but can shown, but but also alsobe also can be can be below closed closed knee) crotch) crotch) H-oneleg I-stump J-torso shirt K-two arm L-short M-long N-wrist open crotchstocking (no sleeves half shirt bodysuit bodysuit to axilla with high(below knee shown, but (two arms (no (sleeves gauntlet leg brief shown,but can also shown, but sleeves shown but also can be have can also beshown, can be no above sleeves) one arm) but can sleeves) knee) also bewith one or two sleeves) O- P-wrist Q- R- S-fingers T-fingers U-wristmetacarpals through metacarpals metacarpals to axilla to wrist to elbowto axilla shoulder through to wrist gauntlet glove glove gauntlet flapgauntlet shoulder glove and glove and glove flap gauntlet and gloveV-elbow to W- X-full face Y-head and wrist glove metacarpals and neckneck cover to elbow mask gauntlet

As would be understood, compression garments must be properly fitted toachieve the therapeutic results in patients where treatment isclinically indicated. In the context of compression therapy in the armregion, at a minimum, an improperly fitted sleeve can reduce theapplication effectiveness of compression therapy by inadequatelyapplying the prescribed compression gradients to the patient's arm.Moreover, an improperly fitted sleeve can make conditions such aslymphedema worse by placing too much or too little pressure on certainareas of the body part or body part area, which can cause fluid backupto worsen. The specific external pressure applied to the body part orbody area can also exert a massaging effect on the body part or bodyarea to enhance the therapeutic action of a compression garment.

The inventors herein have found that prior art measurementinformation—whether derived from measuring the patient directly such asby a tape measure or that is derived from prior art image acquisitiontechniques—used to generate custom fitted compression garments do notadequately take into account the unique shapes, that is, surfacemorphologies of each patient. In this regard, the inventors havedetermined body part or body area shape description and informationderivable therefrom that is derived from shape descriptions obtainedfrom imaging can greatly improve the fit, and therefore, therapeuticefficacy of one or more prescribed compression gradients in patients inneed of compression therapy. Moreover, such shape descriptions andassociated derivable information is particularly useful in persons withcomplex body morphologies, such in people having lobes or folds alongthe body part or body part area where compression therapy is indicated.

In some aspects, the present invention comprises obtaining at least onecompression gradient value prescribed for a patient from a provider.Such prescription will include at least an identification of the bodypart or body part area upon which the compression therapy is to beapplied via a compression garment and one or more compression levels tobe incorporated into the compression garment for use.

Compression gradients are typically expressed in mm of mercury (Hg),where such units are in relation to the pressure applied by the pressuregarment when worn by a patient. Compression gradients that may begenerated for incorporation into compression garments according to themethodology herein are presented in Table 1:

TABLE 2 SAMPLE COMPRESSION GRADIENT VALUES 20-30 mm Hg Mild varicoseveins; arterial insufficiency with venous insufficiency 22-28 mm HgBurns-prevention of hypertrophic scars 30-40 mm Hg Moderate varicoseveins; assist fluid return; leg fatigue; stasis dermatitis;postphlebitic syndrome; post-surgical stripping of sclerosing;post-fracture edema; prophylactic treatment of edema and phlebitis;moderate lymphedema 40-50 mm Hg Chronic venous insufficiency; severestasis dermatitis; severe lymphedema; severe chronic venousinsufficiency; moderate orthostatic hypotension 50-60 mm Hg Severeorthostatic hypotension, severe post-thrombosis; intractable edema

The prescribed compression gradient information, such as, but notlimited to the ranges set out in Table 2, can be incorporated intocompression garment manufacturing processes discussed hereinafter.

As noted previously, the methodology herein can be used to monitor theprogression or regression of edema and other conditions in a patient. Togenerate more accurate detection or diagnosis of the occurrence of edemain a patient in need of detection or diagnosis, a baseline body part orbody part area shape description is obtained after acquisition of aplurality of digital images of a body part or body area of interest fora patient. The shape description and/or any geometric informationtherein or any measurement information derivable therefrom can becompared to subsequent shape description(s) and associated informationacquired for that patient to determine whether edema or other conditionshave changed for the patient over time. Subsequent digital imageacquisitions can be performed at intervals concordant with the medicalpractitioner's standard of care. In some aspects, the subsequent imageacquisitions can be conducted on a daily, weekly or monthly basis. Themethodology herein is suitable for addressing potential or actual edemaof one or more of the upper extremity, lower extremity, head or neck,chest, head or genital areas, as non-limiting examples.

In further aspects, the methods herein can enhance patient access toregular body part or body area examination for the appearance ofedema-related symptoms because the imaging processes herein aresimple-to-use in that the image acquisition steps can suitably beoperated by only minimally trained individuals, as long as highresolution images including clinically accurate information, that is,shape descriptions, geometric information, and/or measurementinformation derived therefrom, of the body part or body area ofinterest. As such, the methodology herein can allow more frequentpatient monitoring than is normally possible with existing edemadetection and monitoring methodologies. In some aspects, the patientimage acquisition step can occur in a location remote from the patient'smedical team. For example, the patient imaging step can be conducted inthe patient's home or other non-clinical setting.

Imaging devices suitable for use in the present invention can compriseany device suitable for generating digital images from which a shapedescription of the body part or body area can be derived therefrom. Onesuch device is the Kinect 2® device from Microsoft Corporation, whichprovides depth maps from the imaging process. Another suitable device isthe Structure IO® system that combines a sensor engageable with an iPad®or other mobile device to generate digital images that can be processedto generate suitably detailed numerical information about the body partor body area of interest for use herein. Still further, imaging devicesthat will increasingly be incorporated into mobile devices can also beused to generate images from which shape descriptions can be generated.The Lenovo Phab2 Pro® is an early example of one of these devices.

The imaging devices can be configurable to generate point cloudsdirectly from the imaging step. In some aspects, the imaging acquisitionstep can be configured to generate as many depth maps as is required ina particular image acquisition process to be able to generate a suitablyinformation dense final point cloud from which a shape description canbe derived therefrom. As an example, one could capture one depth map atevery degree of rotation around a leg of a patient and the process canbe repeated the process at three different heights, which would generate1,080 depth maps that are used to generate the point cloud. The numberof depth maps derivable from the imaging process is dependent, at leastin part, by the frame rate of the capture device and the ability toprocess a suitable amount of data. The ability to generate a shapedescription from an imaging step, and the associated geometric andmeasurement information, is highly influenced by the density of thegenerated point cloud. For example, a point cloud suitable forgenerating a shape description for an average leg has about 50,000unique data points in the point cloud.

To suitably obtain the requisite point cloud data from the imageacquisition step, the image capture device can be operationally engagedwith a device upon which the image acquisition process can be reviewedsubstantially in real-time during acquisition of the plurality ofimages. In this regard, the image capture device is in operational andcommunications engagement with a second device, where the second devicehas a screen that can be reviewed by the person, or operator, who isoperating the image capture device. Alternatively, a second person, oroperator, can be reviewing the image acquisition substantially in realtime, to provide instructions to the first operator where to direct theimage capture device so as to acquire suitable images for use herein. Insome aspects, either or both of the first or second operators can be aperson. In separate aspects, the either or both of the first or secondoperators can be a computer or other computing device. If either or bothof the first or second operators are computers, at least some of theimage acquisition process can be partially or fully automated. Stillfurther, image processing, and any associated image analysis stepconfigurable to provide an edema or other diagnosis, can be by either orboth of a person or a computing device, thereby providing full orpartial automation thereof.

In some aspects, while the plurality of digital images are beingacquired, an operator can review an image acquisition report, such as onthe screen. The operator can then adjust the image acquisition processby acquiring one or more images to address any deficiencies notable inthe report, such as holes, seams, etc. in the acquired depth map, forexample. The image acquisition report can also provide written or spokeninstructions to the operator such as, “get closer to the inner thigh andacquire more images,” for example.

Wireless communications are well-suited to allow enhanced flexibility inimage acquisition. For example, in the handheld method discussedhereinafter, the operator freely rotates the image capture device aroundthe selected body part or body area of interest. With wirelesscommunications engagement between the image capture device and a remotecomputing device to which the acquired digital images can betransmitted, image acquisition flexibility can be enhanced. Suchwireless communication capability between the image capture device andany associated computing devices can be by one or more of Wi-Fi,Bluetooth®, RFID, cellular or the like. As would be recognized, someimage capture devices will be integrated with a mobile device (e.g.,smartphone, tablet, etc.), with the mobile device suitably being inwireless communication with a remote computing device. The mobile devicecan also be a computing device.

Referring to FIG. 4, a process 400 according to the present invention isillustrated. In a first step 405, a body part of or body area of apatient in need of treatment is selected or designated for imaging. Instep 410, digital imaging of the selected body part or body area isperformed, which can be rendered on a screen viewable by the operator inthe form of a depth map. Such acquired images can be processed in 415 togenerate a shape description—that is geometric information—of theselected body part or body area. In step 420, the shape description canbe used in the diagnosis of edema, etc., such as to determine a first(or baseline) amount of edema, etc. in the patient. Alternatively or,optionally, in addition to step 420, in 425 compression garments can begenerated that are specifically configured for the body part or bodyarea, to be worn on the body part or body part area at 430. A monitoringstep 435 incorporates additional image acquisition 410 etc. for thepreviously selected and imaged body part or body area. If the generatedcompression garment is worn in 430, monitoring step 435 can occur toassess whether wearing such compression garment in step 430 results inan improvement or a change in a first amount of the edema, etc., thatwas diagnosed in 420.

In a further aspect, the inventive methods of the present inventioncomprise acquiring digital images of a body part or body area ofinterest using a four-sided imaging technique as disclosed in US PatentApplication Publication No US20160235354, the disclosure of which isincorporated in its entirety by this reference. When digital images areacquired according to the methodology in the '354 Publication, shapedescriptions and measurement information suitable for the diagnosis andmonitoring of edema and other conditions can be obtained. Moreover,compression garments specifically configured for the patient can befabricated from instructions derived from the shape descriptions ormeasurement information. To summarize the image acquisition methodologyin the '354 Publication, generally:

-   -   a. The patient is positioned about 3-5 feet from a Kinect 2®, or        any other suitable imaging device/computing device/software        configuration, where the imaging device is positioned about 2-4        feet from the floor on a platform. The height of the imaging        device is dependent, in part, of whether the upper or lower or        all of the patient's body is being imaged.    -   b. A plurality of digital images, for example about 2 to about        20, are taken of each of the patient's front side, first side,        back side, and second side of the body part or body area. If the        arms are being imaged, the patient can be instructed to hold her        arms at about 90 to about 60 degrees from her side. If the legs        are being imaged, the patient can be instructed for image        acquisition to position her legs as far apart as possible, for        example to allow a gap between her thighs to be visible.    -   c. Once the images are acquired they can be processed to        generate a shape representation of the patient body part or body        area as discussed further herein.

With reference to FIG. 5, shown is a schematic block diagram of acomputing device 500. In some embodiments, among others, the computingdevice 500 may represent a mobile device (e.g., a smartphone, tablet,computer, etc.). Each computing device 500 includes at least oneprocessor circuit, for example, having a processor 503 and a memory 506,both of which are coupled to a local interface 509. To this end, eachcomputing device 500 may comprise, for example, at least one servercomputer or like device, which can be utilized in a cloud basedenvironment. The local interface 509 may comprise, for example, a databus with an accompanying address/control bus or other bus structure ascan be appreciated.

In some embodiments, the computing device 500 can include one or morenetwork/communication interfaces 510. The network/communicationinterfaces 510 may comprise, for example, a wireless transmitter, awireless transceiver, and/or a wireless receiver. As discussed above,the network interface 510 can communicate to a remote computing deviceusing a Bluetooth, WiFi, or other appropriate wireless protocol. As oneskilled in the art can appreciate, other wireless protocols may be usedin the various embodiments of the present disclosure. In addition, thecomputing device 500 can be in communication with one or more imagecapture device(s) 521. In some implementations, an image capture device521 can be incorporated in the computing device 500 and can interfacethrough the locate interface 509.

Stored in the memory 506 are both data and several components that areexecutable by the processor 503. In particular, stored in the memory 506and executable by the processor 503 can be a body shape descriptionprogram 515 and potentially other application program(s) 518. Alsostored in the memory 506 may be a data store 512 and other data. Inaddition, an operating system may be stored in the memory 506 andexecutable by the processor 503.

It is understood that there may be other applications that are stored inthe memory 506 and are executable by the processor 503 as can beappreciated. Where any component discussed herein is implemented in theform of software, any one of a number of programming languages may beemployed such as, for example, C, C++, C#, Objective C, Java®,JavaScript®, Perl, PHP, Visual Basic®, Python®, Ruby, Flash®, or otherprogramming languages.

A number of software components are stored in the memory 506 and areexecutable by the processor 503. In this respect, the term “executable”means a program file that is in a form that can ultimately be run by theprocessor 503. Examples of executable programs may be, for example, acompiled program that can be translated into machine code in a formatthat can be loaded into a random access portion of the memory 506 andrun by the processor 503, source code that may be expressed in properformat such as object code that is capable of being loaded into a randomaccess portion of the memory 506 and executed by the processor 503, orsource code that may be interpreted by another executable program togenerate instructions in a random access portion of the memory 506 to beexecuted by the processor 503, etc. An executable program may be storedin any portion or component of the memory 506 including, for example,random access memory (RAM), read-only memory (ROM), hard drive,solid-state drive, USB flash drive, memory card, optical disc such ascompact disc (CD) or digital versatile disc (DVD), floppy disk, magnetictape, holographic storage, or other memory components.

The memory 506 is defined herein as including both volatile andnonvolatile memory and data storage components. Volatile components arethose that do not retain data values upon loss of power. Nonvolatilecomponents are those that retain data upon a loss of power. Thus, thememory 506 may comprise, for example, random access memory (RAM),read-only memory (ROM), hard disk drives, solid-state drives, USB flashdrives, memory cards accessed via a memory card reader, floppy disksaccessed via an associated floppy disk drive, optical discs accessed viaan optical disc drive, magnetic tapes accessed via an appropriate tapedrive, and/or other memory components, or a combination of any two ormore of these memory components. In addition, the RAM may comprise, forexample, static random access memory (SRAM), dynamic random accessmemory (DRAM), or magnetic random access memory (MRAM) and other suchdevices. The ROM may comprise, for example, a programmable read-onlymemory (PROM), an erasable programmable read-only memory (EPROM), anelectrically erasable programmable read-only memory (EEPROM), or otherlike memory device.

Also, the processor 503 may represent multiple processors 503 and/ormultiple processor cores, and the memory 506 may represent multiplememories 506 that operate in parallel processing circuits, respectively.In such a case, the local interface 509 may be an appropriate networkthat facilitates communication between any two of the multipleprocessors 503, between any processor 503 and any of the memories 506,or between any two of the memories 506, etc. The local interface 509 maycomprise additional systems designed to coordinate this communication,including, for example, performing load balancing. The processor 503 maybe of electrical or of some other available construction.

Although the body shape description program 515 and other applicationprogram(s) 518 described herein may be embodied in software or codeexecuted by general purpose hardware as discussed above, as analternative the same may also be embodied in dedicated hardware or acombination of software/general purpose hardware and dedicated hardware.If embodied in dedicated hardware, each can be implemented as a circuitor state machine that employs any one of or a combination of a number oftechnologies. These technologies may include, but are not limited to,discrete logic circuits having logic gates for implementing variouslogic functions upon an application of one or more data signals,application specific integrated circuits (ASICs) having appropriatelogic gates, field-programmable gate arrays (FPGAs), or othercomponents, etc. Such technologies are generally well known by thoseskilled in the art and, consequently, are not described in detailherein.

Also, any logic or application described herein, including the traverseand tracking program 515 and the application program 518, that comprisessoftware or code can be embodied in any non-transitory computer-readablemedium for use by or in connection with an instruction execution systemsuch as, for example, a processor 503 in a computer system or othersystem. In this sense, the logic may comprise, for example, statementsincluding instructions and declarations that can be fetched from thecomputer-readable medium and executed by the instruction executionsystem. In the context of the present disclosure, a “computer-readablemedium” can be any medium that can contain, store, or maintain the logicor application described herein for use by or in connection with theinstruction execution system.

The computer-readable medium can comprise any one of many physical mediasuch as, for example, magnetic, optical, or semiconductor media. Morespecific examples of a suitable computer-readable medium would include,but are not limited to, magnetic tapes, magnetic floppy diskettes,magnetic hard drives, memory cards, solid-state drives, USB flashdrives, or optical discs. Also, the computer-readable medium may be arandom access memory (RAM) including, for example, static random accessmemory (SRAM) and dynamic random access memory (DRAM), or magneticrandom access memory (MRAM). In addition, the computer-readable mediummay be a read-only memory (ROM), a programmable read-only memory (PROM),an erasable programmable read-only memory (EPROM), an electricallyerasable programmable read-only memory (EEPROM), or other type of memorydevice.

Further, any logic or application described herein, including thetraverse and tracking program 515 and the other application program(s)518, may be implemented and structured in a variety of ways. Forexample, one or more applications described may be implemented asmodules or components of a single application. Further, one or moreapplications described herein may be executed in shared or separatecomputing devices or a combination thereof. For example, a plurality ofthe applications described herein may execute in the same computingdevice 500, or in multiple computing devices in the same computingenvironment 103. To this end, each computing device 500 may comprise,for example, at least one server computer or like device, which can beutilized in a cloud based environment. Additionally, it is understoodthat terms such as “application,” “service,” “system,” “engine,”“module,” and so on may be interchangeable and are not intended to belimiting.

FIG. 6 illustrates a point cloud of a leg obtained by the methodologyabove that suitably provides a shape description of a patient who has alymphedema grade of 1-2, where that shape description can suitably beused as set out elsewhere herein.

In a separate exemplary method of acquiring digital images from whichshape descriptions of a body part or body area of interest can beobtained and from which measurement information can optionally bederived, a provider acquires patient body part or body part area digitalimages using a hand-held technique. Such handheld technique is usefulfor a wide range of edema-related conditions, such as lymphedema atstages 1-3, with stage 3 being particularly relevant to the imagingbenefits resulting from this handheld methodology.

This handheld image acquisition methodology can be conducted as follows.(Note that a Structure Sensor configured with an iPad is used below, butthe technique can be used with any suitable imaging device and computingdevice that uses a software configuration.)

Arm Image Acquisition Technique (shown partially in FIG. 7):

-   -   a. The patient's arm is positioned at approximately 90 degrees        from her body. Generally, the angle can be less than 90 degrees        if indicated by patient mobility range, but for the best imaging        results the angle needs to be large enough to visualize        separation on the Structure Sensor/iPad combination between arm        and body, which is usually a minimum of 60 degrees, depending on        size of patient's arm and body fat percentage.    -   b. The patient's full arm is captured in the frame as shown on        the iPad screen including hand and fingers, with the frame also        being adjusted to include some of the patient's body. The body        serves as a relevant reference point for segmenting the arm for        subsequent image processing.    -   c. The Structure Sensor/iPad combination is held by the operator        who moves the combination laterally along the length of the        patient's arm while capturing views from the top, bottom, and        side planes. While capturing the images, the operator can view        the iPad screen to observe in real time the capture quality of        the image. Such observation ability is particularly useful at        the top and the bottom planes of the patient's arm that have the        highest risk for poor scan quality, especially in patients with        complex morphologies. The operator will typically spend extra        time in these areas.    -   d. Folds or lobes on the patient can require that the operator        rotate the Structure Sensor/iPad combination to capture the        “underside” of the folds.    -   e. Each arm can be captured one at a time in order to maximize        resolution of the scan.    -   f. Some patients can be instructed to hold onto a pole to keep        their arm still or in a stable position. This can be highly        useful for recent surgery or radiation patients because they        often lack arm strength and range of motion.

Leg Image Acquisition Technique:

-   -   a. Patient is instructed to stand with legs wide enough to        achieve separation between legs in the scanning region.    -   b. For low-grade lymphedema, skinny legs, or scans focusing only        on the lower leg, the patient stance is approximately hip-width        apart.    -   c. For higher grades of lymphedema, larger legs (especially        thighs), or when the edema is concentrated in the upper leg,        patient stance may need to be wider.    -   d. Both leg images can be acquired substantially simultaneously.    -   e. The operator positions the segment of the legs in the        scanning window as appropriate—floor to above the knee for lower        leg scan and floor to above the gluteal fold for full leg scan.        The operator can acquire images as she walks 360 degrees around        the patient while also at the same time moving the scanner up        and down.    -   f. The inner side of the patient's legs has the highest risk of        poor scan quality. Because of this it is important that extra        effort is taken to get a clean scan of this area. This can be        done by aiming the sensor directly at the inner side of the leg        and ensuring that all surfaces can be visualized.    -   g. Folds can require that the sensor/tablet combination rotate        to capture the “underside” of the fold. This can be done by the        user positioning the combination at a position that it is below        the patent's skin fold and then aiming it up towards the patient        so the underside of the fold is acquired in a plurality of        images.

Digital image acquisition by a provider's real time or substantiallyreal-time adjustment of received images of the patient body part or bodyareas by movement of the imaging device in space during an imageacquisition process has been found by the inventors herein to beespecially useful when generating measurement information for patientswith complex morphologies, such as patients with advanced edema and/orwho may be obese. In this regard, it has been determined that fixeddistance image acquisition setups (either with patient rotating in placeor camera rotating around patient—even if camera or patient are movingup and down) often cannot acquire accurate reconstructions of body partsor body part areas. Allowing the imaging device to freely move with sixdegrees of freedom, unconstrained by a mounting or support assembly,facilitates more detailed imaging of the patient's body part or bodyareas by acquiring information at a variety of orientations anddistances about the patient. The freedom of movement without constraintallows the imaging to be adjusted for complexities in the surfacemorphology of the patient.

In notable aspects, when the image capture device is rotated around thepatient's body part or body area, the device is not mounted to an arm orrod that rotates around a central point, such as a turntable. Stillfurther, the patient is not rotated on a platform while image capture isunderway. In this way, the images are not captured along a predefinedreference frame. With the image capture device able to move with sixdegrees of freedom, imaging of the patient's body part or body area canbe adapted (e.g., in real time or near real time) to ensure appropriateimaging or focusing on areas that are potentially problematic.

Using the inventive hand-held imaging methodology, the imaging devicecan be rotated or otherwise moved around the patient's body part or bodypart area of interest during image capture, and the image can bereviewed by an operator who is acquiring the images in real time or theimage acquisition process can be reviewed remotely substantially in realtime by someone who is reviewing the image acquisition process in anoffsite location. With the latter, a patient can be imaged in a locationremote to the medical provider, for example by herself or a familymember, to allow the patient's condition to be monitored at a distance,or to allow the compression therapy prescription process and/or thecompression garment measurement processes to occur via telemedicinetechniques.

If, when moving the imaging device around the patient, the operator candetermine that some portion of the patient's body part or region ofinterest is not being well-imaged during the image acquisition step.Such lack of complete image acquisition of the body part or body area ofinterest may be returned on a screen to show “ridges,” “holes,” or“seams” in the body part or body area 3D reconstruction presented to theoperator substantially in real time. By reviewing the 3D reconstructionas it is being generated during image acquisition, the operator canspecifically image that area to generate an improved 3D scan for thatpatient, where shape descriptions and, optionally, measurementinformation for the relevant body part or body area can be derivedtherefrom. This digital image acquisition and real-time review of theacquired images in relation to developing the shape description has beenfound to be especially useful for patients having deep tissue folds,such as for patients with advanced edema/lymphedema and/or who aremorbidly obese.

In this regard, it has been found that prior art fixed plane digitalimage acquisition protocols (either with patient rotating in place orcamera rotating around patient—even if camera or patient are moving upand down) do not allow accurate reconstructions of tissue folds inpatients. Therefore, shape descriptions and associated measurementinformation are not attainable therefrom. Such folds are illustrated inFIG. 1 herewith with a patient presenting with an advanced stage oflymphedema, namely stage 3, in one of her legs.

With regard to the stages of lymphedema, the following informationapplies:

-   -   a. Stage 0 (latent): The lymphatic vessels have sustained some        damage that is not yet apparent. Transport capacity is        sufficient for the amount of lymph being removed. Lymphedema is        not present.    -   b. Stage 1 (spontaneously reversible): Tissue is still at the        pitting stage: when pressed by the fingertips, the affected area        indents and reverses with elevation. Usually upon waking in the        morning, the limb or affected area is normal or almost normal in        size.    -   c. Stage 2 (spontaneously irreversible): The tissue now has a        spongy consistency and is considered non-pitting: when pressed        by the fingertips, the affected area bounces back without        indentation. Fibrosis found in stage 2 lymphedema marks the        beginning of the hardening of the limbs and increasing size.    -   d. Stage 3 (lymphostatic elephantiasis): At this stage, the        swelling is irreversible and usually the limb(s) or affected        area is noticeably large. The tissue is hard (fibrotic) and        unresponsive; some patients consider undergoing reconstructive        surgery, called “debulking”. This remains controversial,        however, since the risks may outweigh the benefits and the        further damage done to the lymphatic system may in fact make the        lymphedema worse.

Still further, lymphedema can be assessed in relation to the severitywith which a clinician grades the patient's presentation:

-   -   a. Grade 1 (mild edema): Involves the distal parts such as a        forearm and hand or a lower leg and foot. The difference in        circumference is less than 4 cm and other tissue changes are not        yet present.    -   b. Grade 2 (moderate edema): involves an entire limb or        corresponding quadrant of the trunk. Difference in circumference        is 4-6 cm. Tissue changes, such as pitting, are apparent. The        patient may experience erysipelas.    -   c. Grade 3a (severe edema): Lymphedema is present in one limb        and its associated trunk quadrant. Circumferential difference is        greater than 6 centimeters. Significant skin alterations, such        as cornification or keratosis, cysts and/or fistulae, are        present. Additionally, the patient may experience repeated        attacks of erysipelas.    -   d. Grade 3b (massive edema): The same symptoms as grade 3a,        except that two or more extremities are affected.    -   e. Grade 4 (gigantic edema): In this stage of lymphedema, the        affected extremities are huge, due to almost complete blockage        of the lymph channels.

The inventors herein have determined that all stages and grades can beassessed with the handheld image acquisition technology herein, whereasthe fixed platform methodology provides clinically accurate results forlymphedema stages 0-2 and grades of 1-2.

Shape descriptions and associated information derivable therefrom of abody part or body area of interest obtained according to the presentinvention can also be used to fit off-the-shelf compression garments forthat patient to provide an improved fitting methodology. The inventivemethodology allows numerically accurate measurement information to beobtained for one or more body parts or body areas of interest (e.g.,arm, leg, trunk, neck, etc.). In contrast to prior art methodology, themeasurement methodology of the present invention provides substantiallyaccurate anthropometric measurements, as well as high resolutioninformation for the relevant body part or body part areas so as toenable excellent reproductions of the person's physique. Furthermore,the invention enables anthropometric measurements to be obtained withoutthe typical in inter-operator error, thereby better standardizing theresultant fit and subsequent performance of the compression garments.

Notably, the methodology of the present invention allows substantiallyaccurate shape description information to be generated in virtually anylocation at which the patient might be located using the imagegeneration and processing methodologies disclosed elsewhere herein. Therelative simplicity of generating the digital images from a specificpatient means that it is possible for patients to take their own imagesin convenient locations. The increased simplicity provides a previouslyunrealized ability to enable regular monitoring of patient body part orbody area measurements, for example, a home setting or in otherextra-clinical settings, thereby greatly enhancing the ability togenerate properly fitted compression garments, be they for therapeutictreatment or otherwise. Because the person can be measured, andtherefore fitted, in their home or other private location, access towell-fitting compression garments for various uses can be greatlyenhanced.

Yet further, one or more or of a plurality of body contour measurementsderived from one or more shape descriptions of a body part or body areaof interest can be combined to form a compression garment configured forwearing by a user. For example, the compression garment of the inventionmay comprise shorts, long tights or tops, either as a single garment orin a combination of garments intended to be worn as a suit. As anexample, an athlete may have arms or legs of different exterior contoursdue to dominance, injury or other factors. The improved measurementcapabilities disclosed herein can enable custom bicycle pants to begenerated for a cyclist with the legs precisely fit to the volume ofthat person when the measurement information is provided to generate apattern or other information suitable to manufacture such a garment. Thepresent invention can also be utilized to generate custom-fittedswimsuits or other athletic apparel where compression comprises at leasta part of the functional aspect incorporated into such garment.

The material of which the compression garment of the invention is mademay be chosen from a wide variety of fabric or different fabrics. Insome aspects, the garment of the invention can be made of panels offabrics of elastane or similar stretch material, often combined withnylon or polyester or similar stretch materials of 40, 60 or up to 120denier material. The fabric can comprise selected stretch and recoverycharacteristics. The stretch along the warp of the fabric can be fromabout 120% to about 225% and its number for recovery is from about 10%to about 25%. The material can incorporate a “wicking” effect, so thatin use it draws moisture from the body. Such materials are known.

As would be recognized, modern knitting machines are highly integratedwith processing controls and software. In this regard, the highlyaccurate measurement information generated from the disclosed herein canbe incorporated in the compression garment fabrication instructionsassociated with use of the knitting machine. Such fabricationinstructions can be transmitted by the imaging devices and associatedequipment via the cloud. Alternatively, the measurements can be providedto the knitting machine by uploading the measurements on a USB device orthe like, as would be known.

Compression garments generated from fabrication information generated bythe inventive methods herein can be made from thicker (but breathable)materials and knitted row by row as a flat piece, which are shaped andproduced by adding or removing needles during the production process,according to the exact measurements of the person. The finished flatpiece can then be joined by a seam to form the garment. Such heavierknit materials can provide greater stiffness resulting in greaterresistance and better containment of the swelling than ready-madegarments (so-called stiffness factor). As such, such thicker materialsare more suitable for applications where a higher compression value isrequired, such as for lymphedema treatment.

Still further, compression garments generated from the inventivefabrication information can be prepared in one piece, such as from acontinuous knitting machine.

Yet further, the inventive measurement methods can be utilized toprovide compression garments with lower compression gradient values,which might be more suitable for sport-type applications. In thisregard, relatively thin and sheer fabrics that are continually knittedin a circular fashion on a cylinder and thus have no seam. As would berecognized, varying stitch height and yarn tension create theappropriate shape and size based on the measurements provided in themanufacture thereof.

The present invention can also comprise patterns for use in preparingcompression garments. Such patterns and any associated compressiongarments will be specifically associated with the body features of theperson being fitted for, and therefore treated with, the compressiongarment. Still further, the methodology herein can be used to select apre-made compression garment of a predetermined size, that is, an “offthe shelf” garment.

Various designs or constructions can be included in the compressiongarment to provide improved functionality relating to compressionactivity. For example, US Patent Application Publication No.20140200494, the disclosure of which is incorporated herein in itsentirety by this reference provides a purported improved functionalitybased upon the knitted pattern in the resulting garment. Yet further,U.S. Pat. No. 9,345,271, the disclosure of which is incorporated hereinin its entirety by this reference, illustrates how variable pressure canbe generated along the length of a compression garment via stitchingtechniques. Yet further, compression garments of the present inventioncan comprise a plurality of panels having variable compression fabricwithin or added over panels of other compression fabric to generateimproved muscle support. Still further, the methodology of the presentinvention allows measurements to be generated to provide compressiongarments where compression can be placed in particular on some joints ormuscles. This, in turn, allows incremental compression to be achieved inthe garment. Such incremental compression has been found to increasestrength and stability on the joints, whilst supporting the muscles.This is a variation on the existing art where the support can be invokedby the wearer, choosing between an active state and a passive state.Such varied compression features can be identified for incorporation asa result of the improved limb or body part shape possible by themeasurement techniques of the present invention.

In addition to the measurement information generated from the person,features relevant to the garment construction can also be incorporatedinto the information used to create the compression garment specificallyconfigured to fit the person. In this regard, the information used tofabricate each compression garment can further include a desiredcompression, a desired compression class, whether the compression needis for prophylaxis, a degree of edema or vascular insufficiency of theperson, or an indication of compression sensitivity of the person, suchas if the person has a skin condition where compression might causedamage to the person. Where the additional information is a positiveindication of compression sensitivity of the person, the expectedcompression of the given garment can be a lowest expected compression ofa set of garments with acceptable expected compression, and the givengarment can be determined to meet the compression need of the person inresponse to the positive indication of compression sensitivity.

In further aspects, the compression garments generated according to themethodology herein can be configured with a plurality of sensors. Thesensors can be utilized to measure and/or diagnose muscle behavior in aperson, such as by assisting in the evaluation of an athlete'sperformance, as disclosed in US Patent Application Publication No.20140259267, the disclosure of which is incorporated herein in itsentirety by this reference. Yet further the one or plurality of sensorscan incorporate functionality that provides therapeutic benefits to auser. In such latter example, the selective constriction and dilationdisclosed in US Patent Application Publication No. 20160120734 isillustrative, of which the disclosure therein is incorporated herein inits entirety.

In one or more aspects, the sensors can be positioned in one or aplurality of locations on a compression garment generated for use on aperson's leg. For example, the one or a plurality of sensors can bepositioned proximal to the person's vastus lateralis, vastus medialis;vastus intermedius, rectus femoris, biceps femoris, semimembranosus,semitendinosus, gastrocnemius, soleus, or plantaris. Yet further, theone or plurality of sensors incorporated in or associated with thecompression garment can be positioned in one or a plurality of positionson a generated for use on a person's arm. In this regard, the one orplurality of sensors incorporated in or associated with the compressiongarment can be positioned proximal to the persons' biceps, triceps,brachioradialis, extensor carpi, radialis longus, or deltoid. Asdescribed elsewhere herein, the improved measurements possible with theinventive methodology herein provide improved fit for the compressiongarments. Similarly, placement of the sensors in the compressiongarments will be improved because the anthropometric measurementtechniques of the present invention can generate better identificationof the relevant locations of a person's arms or legs.

While the present invention is primarily directed toward improvedfitting of compression garments, and garments made therefrom, thepresent invention can also be used to generate anthropometricmeasurements for use to create custom clothing. The variety of garmentsthat can be generated from the inventive anthropometric measurementtechniques are expansive, and are limited only by the desire of personsto have access to custom-fit garments. In non-limiting examples, theinventive measurement techniques herein can be used to generate dresses,suits, trousers, jackets, shapewear, jeans, and the like. Theanthropometric measurements can be provided to a pattern engineer togenerate custom clothing, that is clothing that is created from apattern generated from the measurements of a person for whom the garmentis intended to be worn. With the proliferation of computerized sewingmethods, such as those available in the near future from SoftWearAutomation (Atlanta, Ga.), the anthropometric measurement methods of thepresent invention will increase the accessibility of custom clothing tothe public. Methodologies for generating custom-fit clothing from aperson's measurements are disclosed, for example, in US PatentApplication Publication No. 20140277663, the disclosure of which isincorporated herein in its entirety by this reference.

Yet further, the measurement methodology of the present invention can beused to improve selection of ready to wear clothing for a person. Inthis regard, the anthropometric measurements obtained can be input intoa look up table, for example, to provide improved fit selection for aperson. As an example, a person can obtain measurements that can bematched with the dimensions (or fit characteristics) of various clothingtypes to reduce uncertainty in determining whether a particular type ofclothing will fit the person. Such improved fit probabilities canfacilitate purchases of clothing online, for example. One example ofimproved fit methodologies that can be utilized with the anthropometricmeasurement methodology of the present invention is illustrated in U.S.Pat. No. 7,398,133, the disclosure of which is incorporated herein inits entirety by this reference.

A number of embodiments have been described but a person of skillunderstands that still other embodiments are encompassed by thisdisclosure. It will be appreciated by those skilled in the art thatchanges could be made to the embodiments described above withoutdeparting from the broad inventive concepts thereof. It is understood,therefore, that this disclosure and the inventive concepts are notlimited to the particular embodiments disclosed, but are intended tocover modifications within the spirit and scope of the inventiveconcepts including as defined in the appended claims. Accordingly, theforegoing description of various embodiments does not necessarily implyexclusion. For example, “some” embodiments or “other” embodiments mayinclude all or part of “some”, “other,” “further,” and “certain”embodiments within the scope of this invention.

1. A method for making a compression garment comprising: a) selecting abody part or body area of interest in a patient in need of compressionthereby, the body part or body area having a surface morphology of thatpatient; b) acquiring digital images of the selected body part or bodyarea; c) processing the digital images by a computing device, wherein:i) the processing of the digital images comprises generating shapedescription information for the selected body part or body area; ii) thegenerated shape description information comprises geometric informationfor the selected body part or body area, the geometric information beingassociated with the surface morphology of the selected body part or bodyarea of the patient; and iii) measurement information for the selectedbody part or body area can optionally be derived from the shapedescription information; d) providing at least one compression gradientvalue identified as therapeutically appropriate to provide compressiontherapy to the patient when the at least one compression gradient valueis incorporated into a compression garment fabricated from the shapedescription information or the optional measurement information; and e)fabricating the compression garment from the shape descriptioninformation or the optional measurement information, wherein thefabricated compression garment incorporates the provided compressiongradient value.
 2. The method of claim 1, wherein the selected body partor body area is at least part of one arm or at least part of one leg. 3.The method of claim 1, wherein the digital images are not acquired byrotation of an imaging device on a path about a fixed axis around thepatient or by rotation of the patient on a platform.
 4. The method ofclaim 1, wherein the digital images are acquired by an operator movingan imaging device around the selected body part or body area ofinterest.
 5. The method of claim 4, wherein the imaging device is freeto move around the selected body part or body area with six degrees offreedom, unconstrained by a mounting or support assembly.
 6. The methodof claim 4, wherein the operator observes a digital image acquisitionreport in substantially in real time during the digital imageacquisition step, wherein the image acquisition report includesinformation received about a three-dimensional reconstruction of theselected body part or body area, and wherein the operator can adjust thedigital image acquisition in response to the received information. 7.The method of claim 6, wherein the digital image acquisition report ispresented to the operator on a screen that is in operational engagementwith the image capture device.
 8. The method of claim 1, wherein theselected body part or body area comprises at least one knob or lobe, thesurface morphology of the patient thereby comprising a complex surfacemorphology for the selected body part or body area.
 9. The method ofclaim 1, wherein the compression garment comprises geometric featuresassociated with the selected body part or body area that reduce pinchingor chaffing of the patient.
 10. The method of claim 1, wherein thecompression garment is in the form of an arm sleeve, wherein theprovided compression gradient value is from about 20 to about 50 mm Hg,wherein the compression gradient value is incorporated in an area distalfrom a top end of the sleeve, and wherein the top end is proximal toeither an elbow area or a shoulder area on the patient.
 11. The methodof claim 10, wherein the compression garment comprises geometricfeatures associated with the selected body part or body area that reducepinching or chaffing of the patient.
 12. The method of claim 10, whereinthe compression garment comprises geometric features associated with abony area of the selected body part or body area identified by the shapedescription information.
 13. The method of claim 1, wherein thecompression garment is in the form of a leg covering, wherein thecompression gradient value is from about 20 to about 50 mm Hg, whereinthe compression gradient value is incorporated in an area distal to atop end of the covering, and wherein the top end is proximal to either aknee area or a thigh area on the patient.
 14. The method of claim 13,wherein the compression garment comprises geometric features associatedwith a bony area of the selected body part or body area identified bythe shape description information.
 15. The method of claim 1, wherein atleast part of the selected body part or body area substantially does notcomprise a circular cross-sectional area.
 16. A method for making acompression garment comprising: a) selecting a body part or body area ofinterest in a patient in need of compression thereby, wherein theselected body part or body area comprises at least one knob or lobe,thereby providing a complex surface morphology for the selected bodypart or body area; b) acquiring digital images of the selected body partor body area; c) processing the digital images by a computing device,wherein: i) the processing of the digital images comprises generatingshape description information for the selected body part or body area;ii) the generated shape description information comprises geometricinformation for the selected body part or body area, the geometricinformation being associated with the surface morphology of the selectedbody part or body area of the patient; and iii) measurement informationfor the selected body part or body area can optionally be derived fromthe shape description information; d) providing at least one compressiongradient value identified as therapeutically appropriate to providecompression therapy to the patient when the at least one compressiongradient value is incorporated into a compression garment fabricatedfrom the shape description information or the optional measurementinformation; and e) fabricating the compression garment from the shapedescription information or the optional measurement information, whereinthe fabricated compression garment incorporates the provided compressiongradient value.
 17. The method of claim 16, wherein the selected bodypart or body area is at least part of one arm or at least part of oneleg.
 18. The method of claim 16, wherein the compression garment is inthe form of an arm sleeve, wherein the provided compression gradientvalue is from about 20 to about 50 mm Hg, wherein the compressiongradient value is incorporated in an area distal from a top end of thesleeve, and wherein the top end is proximal to either an elbow area or ashoulder area on the patient.
 19. The method of claim 16, wherein thecompression garment is in the form of a leg covering, wherein thecompression gradient value is from about 20 to about 50 mm Hg, whereinthe compression gradient value is incorporated in an area distal to atop end of the covering, and wherein the top end is proximal to either aknee area or a thigh area on the patient.
 20. The method of claim 16,wherein at least part of the selected body part or body areasubstantially does not comprise a circular cross-sectional area.